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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oxygenator, cardiopulmonary bypass
510(k) Number K211495
Device Name EOS PMP
Applicant
Sorin Group Italia S.R.L
Via Statale 12 Nord. 86
Mirandola,  IT 41037
Applicant Contact Luigi Vecchi
Correspondent
Sorin Group Italia S.R.L
Via Statale 12 Nord. 86
Mirandola,  IT 41037
Correspondent Contact Luigi Vecchi
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/13/2021
Decision Date 07/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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